Ilevro (Nepafenac Ophthalmic Suspension 0.3%)

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

NEPAFENAC

Available from:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

NEPAFENAC

Units in package:

0.5 ml; 3.0 ml

Manufactured by:

S.A. ALCON-COUVREUR N.V.

Patient Information leaflet

ILEVRO
Nepafenac OphthalmicSuspension 0.3%
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Ilevro is used for
2.
How Ilevro works
3.
Before you use Ilevro
4.
How to use Ilevro
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Ilevro
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT ILEVRO
IS USED FOR
Ilevro is used to treat pain and
inflammation associated with cataract
surgery. Ilevro reduce risk of
postoperative macular oedema associated
with cataract surgery in diabetic patients.
HOW ILEVRO WORKS
Ilevro contains the active substance
nepafenac, and belongs to a group of
medicines called nonsteroidal
anti-inflammatory drugs (NSAIDs).
BEFORE YOU USE ILEVRO
_When you must not use it _
Do not use Ilevro:
•
If you are allergic (hypersensitive) to
nepafenac or any of the other
ingredients in Ilevro or to other non-
steroidal anti-inflammatory drugs
_ _
_Before you start use it _
Take special care with Ilevro
•
If you bruise easily or have bleeding
problems or take any medicines that
may cause prolonged bleeding.
•
If you have any eye disorder that may
be aggravated (e.g. dry eyes, corneal
ulceration or epithelial defects).
•
If you have systemic conditions like
diabetes and rheumatoid arthritis.
•
If you have had repeated and /or
complicated eye surgeries.
•
If you wear contact lenses.
•
If you use Steroids or other Topical
NSAIDs (Non-Steroidal Anti
Inflammatory Drugs-Medications) as
these may slow or delay the healing of
your eye wound.
Tell your doctor if any of these apply.
You may still be able to use Ilevro, but
discuss it with your doctor before using
the product.
_Taking other medicines _
Please tell your doctor or pharmacist if
you are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.
Especially tell your doctor if you are
using topical NSAIDs. Concomitant use
of topical steroids and topical NSAIDs
may increase eye healing

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
ILEVRO (Nepafenac Ophthalmic Suspension 0.3%)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of suspension contains 3 mg nepafenac.
Excipient with known effect
Each ml of suspension contains 0.05 mg benzalkonium chloride
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, suspension
Light yellow to dark orange uniform suspension, pH 6.8
(approximately).
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ILEVRO is indicated in adults for:
-
Prevention and treatment of postoperative pain and inflammation
associated with cataract surgery
-
Reduction in the risk of postoperative macular oedema associated with
cataract surgery in diabetic
patients (see section 5.1)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, including the elderly _
For the prevention and treatment of pain and inflammation, the dose is
1 drop of ILEVRO in the
conjunctival sac of the affected eye(s) once a day beginning 1 day
prior to cataract surgery, continued on
the day of surgery and for the first 2 weeks of the postoperative
period. Treatment can be extended to the
first 3 weeks of the postoperative period, as directed by the
clinician. An additional drop should be
administered 30 to 120 minutes prior to surgery.
In clinical trials, patients were treated for up to 21 days with
ILEVRO (see section 5.1).
For the reduction in the risk of postoperative macular oedema
associated with cataract surgery in diabetic
patients, the dose is 1 drop of ILEVRO in the conjunctival sac of the
affected eye(s) once daily beginning
1 day prior to cataract surgery, continued on the day of surgery and
up to 60 days of the postoperative
period as directed by the clinician. An additional drop should be
administered 30 to 120 minutes prior to
surgery.
Once-daily dosing with ILEVRO provides the same total daily dose of
nepafenac as three-times-daily
dosing with NEVANAC (Nepafenac Ophthalmic Suspension 0.1%).
ILEVRO may be administered in conjunction with other topical
ophthalmic medications